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US approves new drug for the treatment of sickle cell disease



United States. On Friday, regulators approved a new drug that can help reduce extremely painful sickle cell disease.

The Food and Drug Administration approved Adakveo from Novartis AG for patients 16 and over. The monthly infusion, which halves the incidence of sickle cell pain episodes, will have a list price of approximately $ 85,000 to $ 113,000 per year, depending on the dosage. Insured patients usually pay less.

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Sickle cell disease is one of the most common inherited blood disorders affecting about 1

00,000 Americans, most of whom are black and about 300 million people worldwide.

It is characterized by periodic episodes in which red blood cells stick together and prevent the blood from reaching organs and small blood vessels. This leads to severe pain and cumulative organ damage, which shorten the lives of people with this disease.

"The duration and severity of these pain crises worsen with age. Patients often die during one of these crises, "Dr. Biree Andemariam, chief physician of the Sickle Cell Disease Association of America.

Novartis Adakveo (Novartis via AP) According to Ameet Mallik, the head of the US oncology and blood department, the longer the patients receive it, the better the drug appears.

The Swiss drug maker continues to test whether Adakveo, also known as crizanlizumab, prolongs patient life disorders.

He said episodes of severe pain sent US patients to the emergency room about 200,000 times a year. About 85% are hospitalized for days up to a week, where high costs are incurred.

The debilitating condition also leads to anemia, retarded growth, vision damage, and painful swelling of the hands and feet, making it difficult for some people to get a job or work school.

Current treatments include a 21-year cancer drug called Hydroxyurea and Endari, which was approved in 2017.

In patient studies, Endari reduced the incidence of pain episodes by about 25% and hydroxyurea by half. Hydroxyurea can cause serious side effects and requires weekly blood tests. Both drugs have a complicated dosage and do not work in some patients – or stop working.

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In a one-year study of 198 patients, these worked The increase in the dose of two Adakveo doses averaged 1.6 pain episodes this year, and 36% had none. One placebo group had three episodes of pain on average over the year, and 17% had none. Side effects of Adakveo included influenza and high fever.

Danielle Jamison from Islandton, South Carolina suffered from sickle cell pain shortly after birth. The 35-year-old previously had half a dozen pain crises, requiring hospitalizations every year. These decreased by about half when they began taking hydroxyurea nine years ago.

She has not been hospitalized since taking crizanlizumab two years ago in a patient study. She still has a slight daily pain, but she said she could now take care of her home and drive her 9-year-old daughter to activities.

"It made a big difference how much I can do." Jamison said.

All three drugs act through different mechanisms so that physicians can switch patients to Adakveo or add them to their current treatment, said Andemariam, director of the Sickle Cell Treatment and Research Program at the University of Connecticut.

Meanwhile, numerous drugs to treat sickle cell disease and gene therapies, possibly to cure them, are being tested.


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